Inguinal HerniaNCT05702710
Minimal Invasive Treatment of Inguinal Hernia in Neonates
An observational study of Inguinal Hernia and Surgery, run by Maltepe University at 1 site in Turkey (Türkiye).
Trial summary
In this study, preoperative physical examination findings, peroperative findings and data, and postoperative follow-up results of newborns who underwent inguinal hernia repair with PIRS ("Percutaneous Internal Ring Suturing") method will be evaluated retrospectively. Read more about this study
- Who is it for?
- Ages 1 day to 28 days
- Conditions the study is for
- Inguinal Hernia, Surgery
- What is being tested?
- Surgery (PIRS)
- How many people
- 34 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Jan 2023to 15 Mar 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 28 days
- All sexes
- No healthy volunteers
- Child
Study population: Neonates <28 days of age undergoing PIRS
Who may be able to join
- Having undergone PIRS surgery at the study institute between October 1, 2015 and January 1, 2023
- Age between 0-28 days
Who cannot join
- Age > 28 days
- Having had surgery with open surgery
- Having another surgical procedure performed in the same session
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Percutaneous Internal Ring Suturing is a Safe and Effective Method in the Minimal Invasive Treatment of Inguinal Hernia in Neonates
In this study, preoperative physical examination findings, peroperative findings and data, and postoperative follow-up results of newborns who underwent inguinal hernia repair with PIRS ("Percutaneous Internal Ring Suturing") method will be evaluated retrospectively.
Read the detailed description
Congenital inguinal hernia is one of the most common surgical pathologies of childhood. Its treatment includes high ligation of the patent processus vaginalis by open or laparoscopic method. There are many described minimally invasive/laparoscopic repair techniques of inguinal hernias in children. One of them is "percutaneous internal ring suturing" or "Percutaneous Inner Ring Suturing".
There are many studies on the PIRS method in children. Two of these studies are prospective clinical studies published previously by the investigators of this study: in the first, the PIRS method was shown to be a safe and effective method for minimally invasive repair of inguinal hernia in children, and in the second, the use of subparalytic laryngeal masks in anesthesia of patients who underwent PIRS was shown to be sufficient for airway protection and anesthesia management in children undergoing laparoscopy.
Although there are many studies on the repair of inguinal hernia in children with PIRS or other minimally invasive methods in the last decade, there are very limited studies on the use of these methods in newborns, a special group of childhood patients. In the literature, there is no study examining only newborn patients. In this context, the study will be a first in the literature.
- Conditions
- Inguinal Hernia, Surgery
- Being tested
- Surgery (PIRS)
- Medical subject headings
- Hernia, Inguinal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgery (PIRS)Other
Also called Percutaneous Internal Ring Suturing
Laparoscopic procedure for repair of inguinal hernia as described in:
- Thomas DT, Göcmen KB, Tulgar S, Boga I. Percutaneous internal ring suturing is a safe and effective method for the minimal invasive treatment of pediatric inguinal hernia: Experience with 250 cases. J Pediatr Surg. 2016 Aug;51(8):1330-5. doi: 10.1016/j.jpedsurg.2015.11.024. Epub 2015 Dec 11. PMID: 26777889.
| Study group | Role | What they receive |
|---|---|---|
| Neonates Undergoing PIRS | All children <28 days of age undergoing PIRS for inguinal hernia repair Receives: Other: Surgery (PIRS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgery Time
Time from skin prep to end of dressing
Measured: Measured as time from skin prep until dressing is performed (approx. 20-30minutes)
Anesthesia Time
Time from induction to awakening
Measured: Measured in minutes from induction to awakening (approx. 30-40minutes)
Presence of Contralateral Patent Processus Vaginalis
Whether a patent processus vaginalis was observed and repaired on laparoscopy
Measured: Measured during surgery (approx. 5-10minutes)
Secondary outcomes (2)
Dose of Muscle Relaxant
None, Subparalytic or Paralytic
Measured: Measured throughout surgery (20-30minutes)
Type of Airway Management Used
ETT (Endotracheal Tube) or LMA (Laryngeal Mask Airway)
Measured: Measured throughout surgery (20-30minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2023
- Study start30 Jan 2023
- Primary completion1 Mar 2023
- Study completion15 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Inguinal HerniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maltepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Assoc. Prof. David T. Thomas, M.D., Maltepe University
- Investigators
- David T Thomas, MD, Principal investigator, Maltepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05702710
- Sponsor's protocol ID
- PIRS003
- Status last verified
- Mar 2023
- First submitted
- 9 Jan 2023
- Last updated
- 3 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Thomas DT, Gocmen KB, Tulgar S, Boga I. Percutaneous internal ring suturing is a safe and effective method for the minimal invasive treatment of pediatric inguinal hernia: Experience with 250 cases. J Pediatr Surg. 2016 Aug;51(8):1330-5. doi: 10.1016/j.jpedsurg.2015.11.024. Epub 2015 Dec 11.
PubMed 26777889Tulgar S, Boga I, Cakiroglu B, Thomas DT. Short-lasting pediatric laparoscopic surgery: Are muscle relaxants necessary? Endotracheal intubation vs. laryngeal mask airway. J Pediatr Surg. 2017 Nov;52(11):1705-1710. doi: 10.1016/j.jpedsurg.2017.02.010. Epub 2017 Feb 20.
PubMed 28249684Ergun E, Yagiz B, Kara YA, Abay AN, Balci O, Eryilmaz S, Ozguner IF, Karaman A, Karaman I. Comparison of laparoscopic percutaneous internal ring suturing method and open inguinal hernia repair in children under 3 months of age. Turk J Surg. 2021 Sep 28;37(3):215-221. doi: 10.47717/turkjsurg.2021.5157. eCollection 2021 Sep.
PubMed 35112055Wolak PK, Strzelecka A, Piotrowska-Gall A, Wolak PP, Piotrowska I, Dabrowska K, Wrobel J, Nowak-Starz G. Percutaneous Internal Ring Suturing (PIRS) - The Benefits of Laparoscopic Inguinal Hernia Repair. Ther Clin Risk Manag. 2022 Feb 22;18:135-144. doi: 10.2147/TCRM.S348197. eCollection 2022.
PubMed 35237037Pogorelic Z, Cohadzic T, Jukic M, Nevescanin Biliskov A. Percutaneous Internal Ring Suturing for the Minimal Invasive Treatment of Pediatric Inguinal Hernia: A 5-Year Single Surgeon Experience. Surg Laparosc Endosc Percutan Tech. 2021 Apr 15;31(2):150-154. doi: 10.1097/SLE.0000000000000878.
PubMed 33234851Wang F, Zhong H, Chen Y, Zhao J, Li Y, Chen J, Dong S. Single-site laparoscopic percutaneous extraperitoneal closure of the internal ring using an epidural and spinal needle: excellent results in 1464 children with inguinal hernia/hydrocele. Surg Endosc. 2017 Jul;31(7):2932-2938. doi: 10.1007/s00464-016-5309-8. Epub 2016 Nov 4.
PubMed 27815740
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Percutaneous Internal Ring Suturing is a Safe and Effective Method in the Minimal Invasive Treatment of Inguinal Hernia in Neonates
- ClinicalTrials.gov ID
- NCT05702710
- Acronym / sponsor ID
- PIRS003
- Conditions
- Inguinal Hernia, Surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Maltepe UniversityUniversity, hospital or other
- Study start
- 30 Jan 2023 (actual)
- Primary completion
- 1 Mar 2023 (actual)
- Study completion
- 15 Mar 2023 (actual)
- First posted
- 27 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this study, preoperative physical examination findings, peroperative findings and data, and postoperative follow-up results of newborns who underwent inguinal hernia repair with PIRS ("Percutaneous Internal Ring Suturing") method will be evaluated retrospectively.
Detailed description
Congenital inguinal hernia is one of the most common surgical pathologies of childhood. Its treatment includes high ligation of the patent processus vaginalis by open or laparoscopic method. There are many described minimally invasive/laparoscopic repair techniques of inguinal hernias in children. One of them is "percutaneous internal ring suturing" or "Percutaneous Inner Ring Suturing".
There are many studies on the PIRS method in children. Two of these studies are prospective clinical studies published previously by the investigators of this study: in the first, the PIRS method was shown to be a safe and effective method for minimally invasive repair of inguinal hernia in children, and in the second, the use of subparalytic laryngeal masks in anesthesia of patients who underwent PIRS was shown to be sufficient for airway protection and anesthesia management in children undergoing laparoscopy.
Although there are many studies on the repair of inguinal hernia in children with PIRS or other minimally invasive methods in the last decade, there are very limited studies on the use of these methods in newborns, a special group of childhood patients. In the literature, there is no study examining only newborn patients. In this context, the study will be a first in the literature.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neonates Undergoing PIRS | – | Other: Surgery (PIRS)All children <28 days of age undergoing PIRS for inguinal hernia repair |
Who may qualify
- Ages
- 1 day to 28 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Neonates <28 days of age undergoing PIRS
Key inclusion criteria (2 listed)
- Having undergone PIRS surgery at the study institute between October 1, 2015 and January 1, 2023
- Age between 0-28 days
Key exclusion criteria (3 listed)
- Age > 28 days
- Having had surgery with open surgery
- Having another surgical procedure performed in the same session
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Surgery (PIRS)Also: Percutaneous Internal Ring SuturingLaparoscopic procedure for repair of inguinal hernia as described in: 1) Thomas DT, Göcmen KB, Tulgar S, Boga I. Percutaneous internal ring suturing is a safe and effective method for the minimal invasive treatment of pediatric inguinal hernia: Experience with 250 cases. J Pediatr Surg. 2016 Aug;51(8):1330-5. doi: 10.1016/j.jpedsurg.2015.11.024. Epub 2015 Dec 11. PMID: 26777889. | Other | Neonates Undergoing PIRS |
Primary outcome
Surgery Time
Time frame: Measured as time from skin prep until dressing is performed (approx. 20-30minutes)
Time from skin prep to end of dressing
Anesthesia Time
Time frame: Measured in minutes from induction to awakening (approx. 30-40minutes)
Time from induction to awakening
Presence of Contralateral Patent Processus Vaginalis
Time frame: Measured during surgery (approx. 5-10minutes)
Whether a patent processus vaginalis was observed and repaired on laparoscopy
2 secondary outcomes
Dose of Muscle Relaxant
Time frame: Measured throughout surgery (20-30minutes)
Type of Airway Management Used
Time frame: Measured throughout surgery (20-30minutes)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2023.
- Background: PubMed 26777889Thomas DT, Gocmen KB, Tulgar S, Boga I. Percutaneous internal ring suturing is a safe and effective method for the minimal invasive treatment of pediatric inguinal hernia: Experience with 250 cases. J Pediatr Surg. 2016 Aug;51(8):1330-5. doi: 10.1016/j.jpedsurg.2015.11.024. Epub 2015 Dec 11.
- Background: PubMed 28249684Tulgar S, Boga I, Cakiroglu B, Thomas DT. Short-lasting pediatric laparoscopic surgery: Are muscle relaxants necessary? Endotracheal intubation vs. laryngeal mask airway. J Pediatr Surg. 2017 Nov;52(11):1705-1710. doi: 10.1016/j.jpedsurg.2017.02.010. Epub 2017 Feb 20.
- Background: PubMed 35112055Ergun E, Yagiz B, Kara YA, Abay AN, Balci O, Eryilmaz S, Ozguner IF, Karaman A, Karaman I. Comparison of laparoscopic percutaneous internal ring suturing method and open inguinal hernia repair in children under 3 months of age. Turk J Surg. 2021 Sep 28;37(3):215-221. doi: 10.47717/turkjsurg.2021.5157. eCollection 2021 Sep.
- Background: PubMed 35237037Wolak PK, Strzelecka A, Piotrowska-Gall A, Wolak PP, Piotrowska I, Dabrowska K, Wrobel J, Nowak-Starz G. Percutaneous Internal Ring Suturing (PIRS) - The Benefits of Laparoscopic Inguinal Hernia Repair. Ther Clin Risk Manag. 2022 Feb 22;18:135-144. doi: 10.2147/TCRM.S348197. eCollection 2022.
- Background: PubMed 33234851Pogorelic Z, Cohadzic T, Jukic M, Nevescanin Biliskov A. Percutaneous Internal Ring Suturing for the Minimal Invasive Treatment of Pediatric Inguinal Hernia: A 5-Year Single Surgeon Experience. Surg Laparosc Endosc Percutan Tech. 2021 Apr 15;31(2):150-154. doi: 10.1097/SLE.0000000000000878.
- Background: PubMed 27815740Wang F, Zhong H, Chen Y, Zhao J, Li Y, Chen J, Dong S. Single-site laparoscopic percutaneous extraperitoneal closure of the internal ring using an epidural and spinal needle: excellent results in 1464 children with inguinal hernia/hydrocele. Surg Endosc. 2017 Jul;31(7):2932-2938. doi: 10.1007/s00464-016-5309-8. Epub 2016 Nov 4.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David T Thomas, MD principal investigator
Maltepe University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Inguinal Hernia and Surgery, run by Maltepe University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgery Time (time frame: Measured as time from skin prep until dressing is performed (approx. 20-30minutes)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05702710, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2023.